CN112957589A

CN112957589A - Balloon catheter retractor

Info

Publication number: CN112957589A
Application number: CN202110190768.XA
Authority: CN
Inventors: 张智超; 马长生; 董建增; 李松南; 汝成韬; 杨伟强
Original assignee: Shanghai Keci Medical Technology Co ltd
Current assignee: Shanghai Keci Medical Technology Co ltd
Priority date: 2021-02-19
Filing date: 2021-02-19
Publication date: 2021-06-15
Also published as: EP4295885A4; EP4295885A1; JP2024507217A; WO2022174557A1; US20240307046A1; US20240008864A1

Abstract

The invention provides a balloon catheter retractor, which comprises a balloon catheter and a balloon fixed on the balloon catheter; when fluid is filled into the saccule, the saccule bends and drives the saccule catheter to bend correspondingly; the balloon expansion limiting device is characterized in that a radial limiting position is applied to the balloon, so that the balloon can not expand in the diameter direction when expanded to a certain diameter. The present invention can enhance its ability to bend and its ability to retain its bending properties.

Description

Balloon catheter retractor

Technical Field

The invention relates to the field of medical instruments, in particular to a balloon catheter retractor.

Background

The existing retractor for retracting esophagus by applying a balloon has the following two schemes:

a balloon with a C-shaped profile was made of a non-compliant material and prior to use residual air within the balloon was evacuated by suction while a rigid straight wire was passed through the balloon axis to align the C-shaped collapsed balloon. When the traction balloon is used, the balloon is sent into an esophageal cavity, after the hard straight guide wire is pulled out, liquid is pumped in and certain liquid pressure (more than 4 atmospheric pressures) is kept, the balloon can be restored to a prefabricated C-shaped structure and provides supporting force, and therefore the traction purpose is achieved. However, in this way, since a non-compliant balloon is used, the initial diameter of the balloon is relatively large, usually greater than 8 mm, and a rigid straight guide wire needs to be embedded when it enters the lumen to ensure its shape during passage. Therefore, such retractors can only access the esophageal tract through the oral cavity under this scheme, but cannot reach the esophageal tract through the nasal cavity. Moreover, since it must pass through the oral cavity, it has a great influence on the patient's feeling, and therefore, it can be used only in general anesthesia (unconscious) patients, but not in conscious patients.

Another retractor uses a semi-compliant balloon that features an off-center axis of the balloon and a local stiffening of the axis of the balloon. Therefore, when the balloon is expanded, the expansion rates of the two sides of the axis of the balloon are different, so that the balloon is bent. Finally, the balloon can form a C-shaped structure along with the expansion of the balloon, thereby achieving the purpose of pulling the esophagus open. However, in this solution, as the balloon is inflated, the material becomes thinner, the pulling force of the balloon is increased and then decreased, and the radial expansion of the balloon hinders the axial expansion of the balloon, so that the difference of the expansion rate of the balloon in the bending direction is reduced, and the bending effect is weakened. Therefore, under this scheme, the pulling force of the balloon is reduced with the passage of time, and the bending force cannot be maintained during the actual use process, so that the clinical requirement cannot be met.

Disclosure of Invention

The invention aims to solve the problems that the existing balloon catheter retractor has large influence on the feeling of a patient and cannot maintain the bending force, and provides a balloon catheter retractor which can enhance the bending capability and the characteristic of keeping the bending performance.

In order to achieve the purpose, the invention provides a balloon catheter retractor, which comprises a balloon catheter and a balloon fixed on the balloon catheter; when fluid is filled into the saccule, the saccule bends and drives the saccule catheter to bend correspondingly; a radial limit is applied to the balloon, so that the balloon can not expand in the diameter direction when expanded to a certain diameter.

Wherein, the sacculus is a sacculus which is manufactured by a semi-compliance sacculus and is eccentric to the axis. The balloon is given a fixed length limitation at the inner side of the axial expected bending direction, and is not limited at the outer side of the axial expected bending direction. The limitation of the inner fixed length of the balloon in the axial intended bending direction may be a rib on the inner side of the bending direction of the balloon. The limitation of the inner fixed length of the balloon in the axial intended bending direction may be to fix a wire on the balloon inside the bending direction of the balloon. The limitation of the inner fixed length of the balloon in the axial intended bending direction may be wires fixed at both ends of the balloon. The radial stop of the balloon may be a mesh, sleeve or another balloon given a fixed diameter. The radial limitation of the balloon can be realized by modifying partial areas of the balloon so as to increase the modulus and rigidity of the partial areas of the balloon.

Preferably, the radial limiting of the balloon is a woven net on the periphery of the balloon, and the woven net has different tensile properties in the radial direction and the axial direction. The warp of the woven net has stronger elastic modulus and is not easy to stretch and has fixed diameter; the weft of the woven mesh has good elasticity, so that the woven mesh has tensile property in the axial direction. The weaving method of the woven net is that the warp threads are denser and the weft threads are more sparse. The two ends of the woven net are fixed at the two ends of the balloon, the net and the balloon are folded and rolled to be used as an initial state, and when the balloon catheter is used, the woven net bends along with the expansion and bending of the balloon in the balloon catheter; when the diameter of the saccule reaches the preset diameter of the woven mesh, the saccule is filled again, and the diameter of the saccule does not change any more. The weft of the woven net is a multi-section short wire, so that the woven net forms a multi-section woven net structure. The multi-section woven net is provided with a plurality of complete wefts on the inner side of the balloon in the axial expected bending direction as fixed length limitation. The weaving net has one or a plurality of weaving net wefts near the inner side of the balloon in the axial expected bending direction replaced by the same material as the warps. The material used for the balloon is anisotropic, having a small elastic modulus in the axial direction and a large elastic modulus in the radial direction. After the balloon is formed, a series of radial reinforcing ribs or reinforcing nets are coated outside the balloon. The outer part of the radial reinforcing rib or the reinforcing net is coated with a polymer film for fixing the reinforcing rib or the reinforcing net.

Furthermore, the radial limiting of the saccule is that a woven mesh is embedded in the saccule, and the inner side and the outer side of the saccule are both made of thermoplastic elastomer materials and are wrapped by the woven mesh.

In addition, the radial limit of the saccule is that a memory metal net with a memory shape of a contraction shape is coated outside the saccule. The diameter of the memory metal mesh is contracted to the original state. The memory metal net is provided with at least one fixed-length memory metal wire at the inner side of the balloon in the axial expected bending direction.

The balloon expansion limiting device has the advantages that a radial limiting position is added to the balloon, and no limitation is added in the axial direction, so that the purpose that the balloon is not expanded in the diameter direction when expanded to a set diameter is achieved, the expansion trend of the balloon is more concentrated on the expansion in the axial direction, and the curvature and the bending rigidity of the balloon are increased. The invention has the significance that the bending strength of the balloon is greatly increased, and meanwhile, the bending strength of the balloon cannot be attenuated along with the time, so that the effect of the balloon for drawing the esophagus is ensured.

In order to make the aforementioned and other objects, features and advantages of the present invention comprehensible, preferred embodiments accompanied with figures are described in detail below.

Drawings

In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the drawings used in the description of the embodiments or the prior art will be briefly described below, and it is obvious that the drawings in the following description are some embodiments of the present invention, and other drawings can be obtained by those skilled in the art without creative efforts.

FIG. 1 is a schematic diagram of one embodiment of the present invention.

Fig. 2 is a cross-sectional view of one embodiment of the present invention.

Fig. 3 is an enlarged view of a partial mesh of a woven mesh according to an embodiment of the present invention.

Fig. 4 is a schematic diagram of a second embodiment of the present invention.

Fig. 5 is an enlarged view schematically showing a knitted net according to a second embodiment of the present invention.

Fig. 6 is a schematic diagram of a third embodiment of the present invention.

Fig. 7 is a schematic view of a fourth embodiment of the present invention.

Fig. 8 is a cross-sectional view of a fourth embodiment of the present invention.

Fig. 9 is a schematic view of a fifth embodiment of the present invention.

FIG. 10 is a schematic view of a memory metal mesh according to the present invention.

Detailed Description

The technical solution in the embodiments of the present invention will be clearly and completely described below with reference to the drawings in the embodiments of the present invention. It is to be understood that the described embodiments are merely exemplary of the invention, and not restrictive of the full scope of the invention. The components of embodiments of the present invention generally described and illustrated in the figures herein may be arranged and designed in a wide variety of different configurations. Thus, the following detailed description of the embodiments of the present invention, presented in the figures, is not intended to limit the scope of the invention, as claimed, but is merely representative of selected embodiments of the invention. All other embodiments, which can be derived by a person skilled in the art from the embodiments of the present invention without making any creative effort, shall fall within the protection scope of the present invention.

The solution of the invention is to add a radial limit to the balloon, and no limit is added in the axial direction, so that the balloon is not expanded in the diameter direction when expanded to a given diameter, and the expansion trend of the balloon is more concentrated on the expansion in the axial direction, thereby achieving the purpose of increasing the curvature and bending rigidity of the balloon.

The scheme is as follows: the balloon is manufactured with the semi-compliant balloon off-center to the axis and then the diameter of the balloon is given a diameter limit. As the balloon is inflated to the desired inflation end diameter, the balloon diameter is no longer inflated, and is not constrained in the axial direction of inflation, and the balloon continues to bend. Over time, this approach may allow the balloon to maintain the degree of curvature and the degree of bending.

The other scheme is as follows: the method comprises the steps of firstly manufacturing a balloon with an eccentric axis by using a semi-compliant balloon, then giving a limit to the diameter direction of the balloon, giving a fixed length limit to the inner side of the expected bending direction of the balloon, and giving no limit to the outer side of the expected bending direction of the balloon. Therefore, as the diameter of the saccule is increased to the preset diameter, the diameter of the saccule is limited by the braided tube, and meanwhile, the length of the inner side in the bending direction is limited by reinforcement, so that the aim of improving the bending force is fulfilled.

The diameter of the restraining balloon may be a mesh, sleeve or another balloon given a fixed diameter; it is also possible to modify a partial region of the balloon to increase the modulus and stiffness of the partial region of the balloon. The axial part of the balloon can be limited by a reinforcing rib, or a wire fixed on the balloon or wires fixed at two ends of the balloon.

The present invention is described in further detail below to enable those skilled in the art to practice the invention with reference to the description.

Referring to fig. 1, fig. 1 is a schematic diagram of an embodiment of the invention. In fig. 1, a balloon catheter retractor 1 is shown, the center of the balloon catheter retractor 1 being an eccentric balloon 12, the periphery of which is a layer of woven mesh 15. The woven mesh 15 makes the tube material formed by the woven mesh have different tensile properties in the radial direction and the axial direction by adjusting the properties of the material on the warp and weft (such as the elastic modulus and the elongation at break) and the weaving method (density on the warp and weft).

Referring next to fig. 2, fig. 2 is a cross-sectional view of an embodiment of the present invention. In fig. 2, three sections of this embodiment from inside to outside can be seen, namely an innermost balloon catheter 13, and a balloon 12 sleeved on the outer layer of the balloon catheter 13, and then a braided mesh 15 sleeved on the balloon 12 at the outermost layer.

Referring to fig. 3, fig. 3 is an enlarged view of a partial mesh of a mesh grid according to an embodiment of the invention. The lines parallel to the balloon catheter axis 10 are defined as woven mesh weft yarns 51, and the lines perpendicular thereto are woven mesh warp yarns 52. The warp 52 of the woven mesh has a high modulus, is not easily stretched and has a constant diameter, and the weft 51 of the woven mesh has good elasticity, and is characterized by having a stretch property in the longitudinal direction.

Both ends of the woven mesh 15 are fixed to both ends of the balloon 12, and the mesh and the balloon are in a folded and rolled state as an initial state by a method of folding and rolling after the fluid in the balloon 12 is exhausted. This ensures that the balloon catheter 13 can meet the delivery requirements of the balloon in the channel before use. Meanwhile, when the scheme is used, the woven net follows the bending along with the expansion and bending of the balloon inside the balloon catheter 13. Meanwhile, after the diameter of the saccule reaches the preset diameter of the woven net, the saccule is filled with the liquid, the diameter of the saccule does not change any more, and the effect of limiting the saccule to expand in diameter is achieved, so that the axial extension of the saccule is enhanced.

Fig. 4 is a schematic diagram of a second embodiment of the present invention. In fig. 4, the balloon catheter retractor 2 is shown, the center of the balloon catheter retractor 2 being the eccentric balloon 12, the periphery of which is a layer of woven mesh 25.

Fig. 5 is an enlarged view schematically showing a knitted net according to a second embodiment of the present invention. Fig. 5 shows an enlarged view of the mesh 25, defining the parallel lines to the balloon catheter axis 10 as mesh weft yarns 61 and the perpendicular lines as mesh warp yarns 62. The warp 62 of the mesh 25 has a strong modulus, is not easily stretched and has a fixed diameter, and the weft of the mesh is a multi-segment short thread so that the mesh forms a multi-segment structure.

Along with the inflation, expansion and bending of the balloon 12, the extending side of the balloon can be freely expanded in the axial direction due to the fact that the weft is a plurality of short lines without being bound by the length of the whole weft, and the warp 61 touching the woven mesh 25 along with the inflation of the balloon in the radial direction is limited in the radial direction, so that greater deformation is provided for the axial expansion of the balloon, and the balloon can keep the bending degree and the rigidity.

Fig. 6 is a schematic diagram of a third embodiment of the present invention. Fig. 6 shows the balloon catheter retractor 3 with a radially reinforced balloon 32 in the center of the balloon catheter retractor 3. This balloon 32 is characterized by being freely expandable in the axial direction without being further expanded to increase its diameter after being expanded in the diametrical direction to a given diameter. The specific scheme comprises the following steps: the material used for balloon 32 is anisotropic and is characterized by a relatively low elastic modulus in the axial direction and a relatively high elastic modulus in the radial direction. Or after the balloon 32 is molded, a series of radial reinforcing ribs or reinforcing nets are coated outside the balloon, and then a polymer film is coated outside the balloon for fixing the reinforcing ribs or the reinforcing nets, so that the outer surface of the balloon is smooth, and the reinforcing ribs or the reinforcing nets inside the balloon are relatively fixed.

Fig. 7 is a schematic view of a fourth embodiment of the present invention. Fig. 7 shows the balloon catheter retractor 4 with a mesh-in-wire reinforced balloon 42 in the center of the balloon catheter retractor 4. This balloon 42 is characterized in that it is slightly axially contracted during its diametrical expansion, and when it is diametrically expanded to the desired diameter, it is fixed in shape so that the entire balloon is not expanded in the radial direction but in the axial direction. The detailed structure is shown in fig. 8, and fig. 8 is a cross-sectional view of a fourth embodiment of the present invention. In fig. 8, the balloon 42 can be seen to be divided into a balloon inner side 43, a sandwich mesh 44 and a balloon outer layer 45. The balloon inner side 43 and the balloon outer side 45 are both made of thermoplastic elastomer materials and are covered with a woven mesh 44. With the radial expansion of the balloon, the woven mesh 44 deforms, but the deformation of the woven mesh 44 reaches the end point due to the existence of the thermoplastic elastomer, so that the effect that the balloon does not expand in the diameter direction and continues to expand in the axial direction is achieved. During the deformation process, the shape of the mesh of the woven mesh tends to change, but the polymer material in the mesh tends to keep the original shape, so that the mesh is resisted, and the deformation of the woven mesh is limited.

Fig. 9 is a schematic view of a fifth embodiment of the present invention. Fig. 9 shows the balloon catheter retractor 5 with an eccentric balloon 12 in the center of the balloon catheter retractor 5, which is covered by a memory metal mesh 91, the memory metal mesh 91 being characterized by its memory shape being a contracted shape. As the balloon 12 is inflated, its diameter expands against the surface of the balloon 12 but its length does not. With the deformation of the memory metal mesh 91, the radial ring of the memory metal mesh is straightened into a circular ring to limit the expansion of the diameter of the balloon, the radial length of the memory metal mesh cannot be changed, and meanwhile, no metal wire is arranged on the expansion side of the balloon to limit the extension of the balloon, so that the diameter of the balloon 12 after being bent is limited by the memory metal mesh 91, the bending of the balloon is not limited, and the performance of enhancing the bending force of the balloon and keeping the bending shape is achieved. Another advantage of this embodiment is that as the balloon 12 is contracted, the diameter of the memory metal mesh 91 will contract to its original state due to its memory property, thereby achieving the effect of coating on the balloon catheter, reducing the volume of the instrument after contraction, and facilitating its passing through when withdrawing.

A further preferred reinforcement of the invention is to add a fixed length of rib to the balloon axially inward of the intended direction of curvature. Thereby increasing the balloon's fixed length constraint inboard of the balloon's axial intended direction of curvature.

Referring again to fig. 1-3, a first balloon catheter retractor solution is shown. Under the scheme, one or a plurality of weaving mesh wefts 51 near the inner side 18 of the balloon 12 in the axial expected bending direction are replaced by the same material as the radial line 52, so that the length of the mesh on the inner side 18 in the axial expected bending direction is not changed, and the bending effect of the balloon is enhanced from the outside. As the balloon is inflated, the balloon and the mesh 15 are pressed against each other, and a large friction force is generated, so that the balloon and the mesh are relatively fixed. As the balloon is bent, the length of the inner side 18 of the balloon in the axial expected bending direction is fixed by the balloon catheter 13 and the weft of the inner side 18 of the axial expected bending direction, so that the length difference between the inner side 18 of the balloon in the axial expected bending direction and the extension side 17 is not reduced with the time, and the capability of keeping the bending shape and the bending force of the balloon catheter 1 is achieved.

Refer again to fig. 4 and 5. In this case, several weft yarns 51 on the inner side 18 in the intended bending direction in the axial direction of the multi-stage woven mesh 25 are reinforced, so that the characteristic that the inner side in the intended bending direction in the axial direction is less likely to be elongated is achieved, thereby enhancing the balloon bending effect.

Refer again to fig. 9 and 10. Wherein FIG. 10 is a schematic view of the memory metal mesh of the present invention. In this way, since the ductility of the memory metal in the linear direction is more difficult to be extended than that of the polymer material, holding at least one memory metal wire of a fixed length on the inner side 18 of the balloon catheter 13 in the intended bending direction can make the inner side 18 of the balloon catheter 13 in the intended bending direction non-ductile during bending, and the ductility on the extending side 17 of the balloon catheter can be maintained to achieve a stronger bending effect.

Bending although embodiments of the present invention have been disclosed above, it is not limited to the applications listed in the description and the embodiments. It can be applied to all kinds of fields suitable for the present invention. Additional modifications will readily occur to those skilled in the art. Therefore, the invention is not to be limited to the specific details and illustrations shown and described herein, without departing from the general concept defined by the claims and their equivalents.

Claims

1. The balloon catheter retractor comprises a balloon catheter and a balloon fixed on the balloon catheter; when fluid is filled into the saccule, the saccule bends and drives the saccule catheter to bend correspondingly; the balloon expansion limiting device is characterized in that a radial limiting position is applied to the balloon, so that the balloon can not expand in the diameter direction when expanded to a certain diameter.

2. The balloon catheter retractor of claim 1, wherein said balloon is a semi-compliant balloon manufactured off-center to the axis.

3. A balloon catheter retractor according to claim 1, wherein said balloon is constrained to a fixed length axially inboard of the intended direction of curvature and unconstrained axially outboard of the intended direction of curvature.

4. A balloon catheter retractor according to claim 3, wherein the constraint of the inner extent of the balloon in the axial direction of intended curvature is a stiffener on the inner extent of the balloon in the direction of curvature.

5. A balloon catheter retractor according to claim 3, wherein the constraint to fix the length of the balloon axially inside the intended direction of curvature is to fix a wire on the balloon inside the direction of curvature of the balloon.

6. A balloon catheter retractor according to claim 3, wherein the constraint of the inner extent of the balloon in the axial direction of intended curvature is a wire attached to each end of the balloon.

7. A balloon catheter retractor according to claim 1, wherein the radial stop of the balloon is a mesh, sleeve or another balloon given a fixed diameter.

8. A balloon catheter retractor according to claim 1, wherein the radial retention of the balloon is achieved by modifying a portion of the balloon to increase the modulus and stiffness of the balloon portion.

9. A balloon catheter retractor according to claim 1, wherein the radial stop of the balloon is a woven mesh around the circumference of the balloon, said woven mesh having different stretch characteristics in the radial and axial directions.

10. A balloon catheter retractor according to claim 9, wherein the warp of said woven mesh has a high modulus of elasticity and is not easily stretched to a fixed diameter; the weft of the woven mesh has good elasticity, so that the woven mesh has tensile property in the axial direction.

11. A balloon catheter retractor according to claim 9 wherein said woven mesh is woven with a denser mesh on the warp and a finer mesh on the weft.

12. A balloon catheter retractor according to claim 9, wherein both ends of the woven mesh are fixed to both ends of the balloon, and the mesh and the balloon are folded and rolled up as an initial state, and when in use, the woven mesh follows the bending as the balloon inside the balloon catheter expands and bends; when the diameter of the saccule reaches the preset diameter of the woven mesh, the saccule is filled again, and the diameter of the saccule does not change any more.

13. A balloon catheter retractor according to claim 9 wherein the weft of said woven mesh is a plurality of segments of staple such that the woven mesh forms a multi-segment woven mesh structure.

14. A balloon catheter retractor according to claim 13 wherein said multi-segmented woven mesh has several intact wefts as a fixed length restriction inboard of the intended axial curvature of the balloon.

15. A balloon catheter retractor according to claim 9, wherein the woven mesh has one or more weft threads of the woven mesh substituted with the same material as the warp threads on the inner side of the balloon in the desired axial bending direction.

16. A balloon catheter retractor according to claim 1, wherein said radial stop of said balloon is that said balloon is made of an anisotropic material having a relatively low elastic modulus in the axial direction and a relatively high elastic modulus in the radial direction.

17. A balloon catheter retractor according to claim 1 wherein the radial balloon restraint is provided by a series of radial ribs or reinforcing mesh applied to the balloon after it has been formed.

18. A balloon catheter retractor according to claim 17, wherein said radial ribs or said reinforcing mesh are coated with a polymeric film for securing said ribs or said reinforcing mesh.

19. The balloon catheter retractor according to claim 1, wherein the radial position of the balloon is limited by a woven mesh embedded in the balloon, and the inner side and the outer side of the balloon are both made of thermoplastic elastomer materials and coated with the woven mesh.

20. The balloon catheter retractor according to claim 1, wherein said radial retention of said balloon is by attaching a memory metal mesh having a memory shape of a contracted shape to said balloon.

21. A balloon catheter retractor according to claim 20, wherein said memory metal mesh is of a diameter which contracts to an original state.

22. A balloon catheter retractor according to claim 20 wherein the memory wire mesh of the balloon catheter retractor retains at least one memory wire of fixed length on the inside of the balloon in the direction of intended axial curvature.